Specifically, the tubes or pipes used in the biopharmaceutical field are flexible or highly flexible pipes which are used to convey various biopharmaceutical substances, most often with the necessary aseptic precautions.
Fluid connection devices commonly comprise a first male connector (in other words forming a male interface) able to be received in a second complementary connector forming a female interface, which is a simple and well-understood solution. However, a male connector cannot be connected to another male connector, nor can a female connector be connected to another female connector.
In the context of assembling a flexible pipe to another pipe or container by means of a fluid connection, there is a need to improve the interoperability of the connectors in order to facilitate the construction of modular biopharmaceutical assemblies.
There are known fluidic connections for connecting together two “genderless” connectors that are functionally equivalent in terms of coupling. However, the known genderless fluid connectors generally require an axial insertion movement followed by a rotational movement about the axis.
In addition, the sterile or aseptic precautions for such applications necessitate good verification of the fluid connections established between the various entities in a biopharmaceutical assembly such as pipes, bags, filters, etc.
We therefore seek ways to check the coupling position in a simple and reliable manner, meaning to verify that the coupling movement has reached the correct final position, possibly being secured in this position by locking means.
For genderless connectors with axial translational movement followed by rotation, proper completion of the rotation is difficult to verify.
There is therefore a first need to provide a connection device for connecting together two genderless connectors with a coupling movement that only involves axial translational movement.
In biopharmaceutical applications, the flexible pipes allow the circulation, passage, and communication of a fluid, such as a biopharmaceutical fluid, and can either be connected to a similar flexible pipe or to a vessel or container which may be rigid or flexible.
The vessel or container in question may, in the current case, be a container for storing and/or processing content such as a biopharmaceutical product. In the current case, such a container is understood to mean a rigid or semi-rigid reusable container or a flexible disposable container such as a bag or even a filter cartridge.
This bag may be one of the substantially thin “2D” bags, such as those marketed by Sartorius Stedim Biotech under the brand Flexboy®, having a typical volume of between 50 ml and 50 liters. This flexible bag may also be a “3D” bag, such as those marketed by Sartorius Stedim Biotech under the brand Flexel®, having a larger volume and a substantial size in all three dimensions. Note that a pipe such as the pipe to which the invention applies can be placed between two bags or a larger number of bags.
A pipe such as that to which the invention is applied, usually of circular cross-section, is typically made of a plastic such as silicone, thermoplastic elastomers (TPE), or PVC, this list being non-limiting. It has a certain general stability and simultaneously both a certain overall flexibility and a certain local flexibility, allowing, when sufficient force is applied, crimping the pipe or substantially deforming it radially.
In a typical embodiment, for example, the pipe has an outer diameter between 8 mm and 30 mm for example, with the thickness depending on the material, the diameter, and the applications.
In the prior art, to couple such a flexible pipe, it is slipped over a tubular nozzle, whereupon a pipe clamp is placed around the pipe and then the clamp is tightened. The tightened clamp thus exerts a radial inward pressure to maintain the hose on the nozzle, on the one hand to ensure a good seal against the nozzle and on the other hand to prevent the pipe from detaching from the nozzle when pulled.
For such pipe clamps, a plastic clamp can be used for example, of polyamide for example such as Rilsan®. This type of plastic clamp, also sometimes called Serflex®, comprises a system of notches on a strip cooperating with a locking hook arranged in the head, such that the tightening is irreversible. In other words, once the strip is engaged in the head to form a loop, the strip is pulled to reduce the diameter of the loop and tighten the clamp; all return movement is prevented by the engagement of the hook in one of the strip notches. After tightening, to prevent the strip from projecting too far beyond the diameter of the clamp loop, the free portion of the strip is cut off near the head of the clamp. The undetached remaining portion of the strip often has a sharp edge which can cut.
As an alternative to the plastic clamp, a metal clamp can be used which is in the form of a preformed ring having one or two “ears” projecting outward with respect to the general shape of the ring of the clamp, this type of clamp sometimes being called an Oetiker® clamp. After insertion of the clamp onto the pipe to be retained, a tool is used to crimp the ear (or ears) of the clamp which causes permanent deformation and thus a narrowing of the major diameter of the ring and as a result tightens the clamp on the pipe. This type of clamping with a metal ring is particularly robust and reliable. However, at the point where the ear was crimped by the tool, there may be a burr or roughness which forms a sharp edge that can be damaging.
Whether plastic or metal, once such clamps are installed in biopharmaceutical assemblies, these assemblies may need to be transported or moved and therefore there is a risk of damage by the damaging parts of these clamps to other elements of the biopharmaceutical assembly, particularly the flexible bags or flexible pipes, which can cause a leakage or loss of sterilization that is detrimental to the biopharmaceutical application.
In addition, these clamps are easy to access (and thus can be removed) and does not guarantee a satisfactory image or aesthetics.
There is therefore a second need to prevent the pipe clamp from posing a danger to the surrounding elements.